Application Engineer

TOMZ Corporation; Berlin (CT); On-site; USD 90,000 - 120,000; Full time

Job summary

TOMZ Corporation in Berlin, CT is seeking a Quality Engineer to guide design & development with a focus on quality design controls and process validation.

You will collaborate with R&D and manufacturing to implement robust quality plans, risk assessments, and supplier qualifications while ensuring compliance with ISO 9001, ISO 13485, and 21 CFR 820.

Experience with audits by customers and regulators, plus strong English communication and proficiency in MS Office, are essential.

Qualifications

• Minimum 4-year degree or equivalent in engineering or quality discipline.
• 2–5 years’ experience in a regulated manufacturing environment.
• Medical device manufacturing experience in regulated environments (Class I–III).
• Knowledge of ISO 9001/13485, 21 CFR 820, EU MDR.
• ASQ CQE or equivalent quality certification is preferred.
• Strong verbal and written English communication.
• Proficiency with Microsoft Office.
• Self-starter with ability to collaborate across R&D, Manufacturing, and QA.

Responsibilities

• Develop and execute Quality Plans for Design & Development projects.
• Collaborate with engineering to update Risk Management documentation.
• Establish severity and risk-based validation strategies with V&V rationales.
• Support qualifications for customer manufacturing processes and supplier audits.
• Drive Test Method development and validations.
• Implement inspection plans for Incoming, In-Process and Final Product.
• Represent Quality Engineering in design reviews.
• Support audits by customers and regulatory agencies.
• Apply systematic problem-solving to quality issues and nonconformances.
• Ensure site Quality Management System compliance.

Skills

Statistical techniques

Quality certifications

First Article Inspections

Auditing

English communication

Cross-functional collaboration

Microsoft Office

Independent work

Education

Bachelors degree or higher in Engineering/Quality

Job description

TOMZ Corporation is looking for a highly motivated Quality Engineer to join our team in Berlin, CT!!

Summary Of Position

Reporting to the Quality Engineering Manager, this position will be responsible for the activities associated with Quality Design & Development (QD&D) Control and Assurance during Product Development Process (PDP) activities as well as continuation design & development support for sustaining manufacturing and product distribution.

Essential Functions

• Develop and execute Quality Plans for Quality Product Design and Development projects.
• Collaborate with engineering teams to initiate and support the development and updates of Risk Management documentation in accordance with project requirements.
• Establish severity and risk-based Process Master Validation Plan strategies with appropriate V&V rationales.
• Support operational and process qualifications for customer manufacturing processes in collaboration with engineering teams.
• Drive Test Method development with Operational and Business considerations and execution of Test Method Validations to measure effectiveness.
• Implement inspection plans for Incoming, In-Process and Final Product.
• Develop and justify appropriate sampling plans with characterization of test and inspection methods.
• Represent Quality Engineering in design reviews.
• Support initial qualification audit activities for Customer and Regulatory Agencies.
• Support qualification activities related to supplier and vendor design characterization requirements for projects, including conducting audits and assessments.
• Support Quality Best Practices and contribute to continuous improvement in GDP/GMP.
• Apply sound, systematic problem-solving methods in identifying, prioritizing, communicating, and resolving quality issues.
• Ensure that all site personnel comply with the site-level Quality Management System and training requirements.
• Support the development of Quality Agreements for external customers.
• Adhere to the TOMZ Quality Management System.
• Perform other duties as assigned.

Qualifications

• Advanced Post-Secondary Education, Training or Certification coursework.
• Knowledge of statistical techniques to analyze process capability.
• Quality certification(s) (e.g., ASQ CQE, QCI, etc.).
• Skilled in First Article Inspections and Component Qualifications.
• Knowledge and experience with external standards: ISO 900/9001, ISO 13485, and 21CFR 820, EU MDR, pertaining to product development, design controls, good manufacturing practices, supplier qualification, auditing, quality control (GD&T, Nonconforming Materials, MRB), Corrective and Preventive Actions, and customer complaints).
• Experience in effectively supporting audits by customers and external regulatory agencies.
• Strong verbal and written English language communication skills.
• Successfully meet TOMZ-specific positional and functional on-the-job training requirements.
• Proficiency with Microsoft Office.
• A self-starter capable of working independently and as part of a team, with the ability to collaborate across various functional areas, including R&D, Manufacturing, and QA, to achieve results.

Education

• Minimum 4-Year degree or equivalent of directly transferrable industry work experience (Engineering or Quality discipline preferred).

Experience

• Minimum of 2-5 years’ experience in a regulated manufacturing environment.
• Experience in Class I, II, and/or III medical device manufacturing within a regulated environment (e.g., Aerospace, Defense, Pharmaceutical, etc.).

Physical Requirements

• Ability to bend, stoop, squat, kneel, and lift up to 50 pounds. Team lift or mechanical assistance required for objects over 50 pounds.
• Ability to sit for prolonged periods.
• Exposure to oil, grease, occupational noise, cleaning solvents, dust, metal particles, sparks, coolant, and sharp-edged materials. Personal protective equipment (PPE) such as safety glasses, dust masks, ear plugs, cut-resistant or chemical-resistant gloves, and engineering controls may be required.
• Perform keyboard entries with frequent operation of a computer.